Actively Recruiting
Decreasing Risk of Psychosis by Sulforaphane (DROPS Trial)
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2023-10-31
300
Participants Needed
9
Research Sites
389 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiao Tong University School of Medicine
Lead Sponsor
S
Shanghai Xuhui District Mental Health Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a randomized, double-blind, placebo-controlled, multi-centre trial. A total of 300 CHR subjects will be identified in the course of face-to-face interviews using the Structured Interview for Prodromal Syndromes. All participants will be randomly allocated to SFN group (n = 150) or placebo group (n = 150). The study duration includes an intervention for 52 consecutive weeks, and additional 1-year follow-up. The primary outcome is 2-year conversion rate of psychosis. Secondary outcomes include 1-year conversion rate of psychosis, the severity and duration of prodromal symptoms, predictive risk of psychosis conversion, neurocognitive functioning and peripheral blood biomarkers of inflammation, oxidative stress and metabolism. Safety monitoring will be performed using scales for side effect, serious adverse events recording, and laboratory tests.
CONDITIONS
Official Title
Decreasing Risk of Psychosis by Sulforaphane (DROPS Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet criteria for Clinical High Risk (CHR) according to the Structured Interview for Prodromal Syndromes (SIPS)
- No prior treatment with antipsychotics or mood stabilizers at first study visit
- Age between 15 and 45 years
- Ability to understand and sign informed consent (patients or legal guardians for those under 18)
- Agree to take study treatments and complete all visits and exams
You will not qualify if you...
- History of schizophrenia or other psychotic disorders
- Severe physical diseases such as cardiac, neurologic, brain trauma, liver, kidney, hematopoietic, or immune system dysfunction, cancer, or other serious illnesses
- IQ below 70 or diagnosis of developmental delay or intellectual disability
- Abnormal lab tests with clinical significance affecting safety
- Past or current abuse of alcohol, amphetamines, or other psychostimulants
- Suicidal thoughts, plans, or behavior in the last 3 months
- Clinically significant allergy to broccoli
- Pregnancy, planning pregnancy, or lactation
- Participation in another clinical trial within the past 30 days
- Other conditions making participation unsafe or unsuitable as determined by investigators
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Guangzhou Psychiatric Hospital
Guangzhou, Guangdong, China, 510009
Not Yet Recruiting
2
the First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Not Yet Recruiting
3
Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
Actively Recruiting
4
Suzhou Psychiatric Hospital
Suzhou, Jiangsu, China, 201300
Actively Recruiting
5
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
6
Shanghai Xuhui District Mental Health Center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
7
Shanghai Pudong Nanhui Mental Health Center
Shanghai, Shanghai Municipality, China, 201300
Not Yet Recruiting
8
Shenzhen Kangning Hospital
Shenzhen, Shenzhen, China, 518118
Actively Recruiting
9
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
J
Jijun Wang, PhD
CONTACT
Z
Zhixing Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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